S100-β Protein Detection Kit (Microfluidic Immunofluorescence Method)
- Device class
- Class II
- Model specifications
- 1 serving/box, 5 servings/box, 20 servings/box, 25 servings/box, 50 servings/box, 100 servings/box1人份/盒、5人份/盒、20人份/盒、25人份/盒、50人份/盒、100人份/盒
- Approval department
- Jiangsu Provincial Drug Administration江苏省药品监督管理局
- Registration number
- 苏械注准20232400091
- Approval date
- January 16, 2023
- Expiry date
- January 15, 2028
- Name
- Lansion Biotechnology Co., Ltd.南京岚煜生物科技有限公司
- Province/Region
- Jiangsu江苏
- Address
- No. 2, Qiande Road, Science Park, Jiangning District, Nanjing南京市江宁区科学园乾德路2号
- Production address
- 南京市江宁区科学园乾德路2号第5号楼1层、3号楼一层西侧、3号楼二层西侧、9号楼1层2层
It is used for the quantitative detection of S100-β protein (S100-β) content in human whole blood, serum and plasma samples in vitro.
用于体外定量检测人全血、血清、血浆样本中的S100-β蛋白（S100-β）含量。
1. S100-β protein microfluidic reagent chip: 1 person/bag detection chip is composed of shell, blood filter pad, absorbent paper and conductive rubber, the internal reaction chamber of the chip is fixed with S100-β murine monoclonal antibody 1 (effective mass of about 0.27μg/person), and S100-β murine antibody 2 fixed by fluorescent microspheres is spotted in the reaction chamber (effective mass is about 0.15μg/person). 2. Other components: manual, calibration curve (QR code).
1.S100-β蛋白微流控试剂芯片：1人份/袋检测芯片由外壳、滤血垫、吸水纸以及导电橡胶组成，芯片内部反应腔固定有S100-β鼠单抗1（有效质量约0.27μg/人份）、反应腔内点样有荧光微球固定的S100-β鼠单抗2（有效质量约0.15μg/人份）。2.其他组成：说明书、校准曲线（二维码）。
The chips in the kit are stored in a sealed foil bag at 2°C-8°C for 12 months. The chip after the aluminum foil bag is unpacked can be stable for 1 hour at room temperature (10°C-30°C).
试剂盒中芯片在铝箔袋密封状态下存放于2℃-8℃，有效期12个月。铝箔袋拆封后的芯片，在常温（10℃-30℃）下可稳定1小时。
Access comprehensive regulatory information for S100-β Protein Detection Kit (Microfluidic Immunofluorescence Method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 苏械注准20232400091 and owned by Lansion Biotechnology Co., Ltd.. The device was approved on January 16, 2023.
This page provides complete registration details including registrant information, province location (Jiangsu), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.